Recall Z-0827-2018— Siemens Healthcare Diagnostics

Name: FDA recall Z-0827-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2017-10-17, terminated 2019-11-04. It names one FDA 510(k) clearance: K970645. Product: BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.. Reason: The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use)..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2019-11-04
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K970645 — BC THROMBIN REAGENTBehring Diagnostics, Inc.·cleared 1997-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.

Reason for recall

The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).

Data sourced from openFDA. This site is unofficial and independent of the FDA.